Pentosan Polysulfate Treatment's Effectiveness

• Sponsor: Hisar Intercontinental Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05744908
• Collaborator: (none)
• Enrollment: 37
• Locations: 2
• Arms: 2
• Actual Duration (Months): 60.3
• Patients Per Site: 18.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

To examine the relationship between symptoms and quality of life before and after oral pentosan polysulfate (PPS) treatment in cases diagnosed with interstitial cystitis/painful bladder syndrome (IC/BPS).

Condition or Disease	Intervention/Treatment	Phase
Chronic Interstitial Cystitis	Other: Pentosan Polysulphate	N/A

Detailed Description

Demographic characteristics, medical history, clinical conditions, and laboratory and cystoscopic data of patients who applied to our clinic between January 2018 and December 2021 and were diagnosed with IC/BPS were retrospectively analyzed. Adult male and female patients with IC/BPS who received 300 mg/day PPS at least six months ago with complaints of pain, urge, frequency, and nocturia not associated with urinary tract infection were included in the study. In addition, pre- and post-treatment symptoms, ICSI scores, quality of life (scored between 1-4), and satisfaction were compared.

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: two models: with and without Hunner's ulcertwo models: with and without Hunner's ulcer
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Retrospective Evaluation of the Effectiveness of Oral Pentosan Polysulfate Treatment in the Improvement of Chronic Interstitial Cystitis Symptoms.
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Jan 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: With Hunner's ulcer Pentosan Polysulfate 100 mg	Other: Pentosan Polysulphate; 300mg 3 times a day
Active Comparator: Without Hunner's ulcer Pentosan Polysulfate 100 mg	Other: Pentosan Polysulphate; 300mg 3 times a day

Outcome Measures

Primary Outcome Measures

1. bladder wall thickness [Three months]

   0.3 over 3 mm 1 under 3 mm,

2. improvement of lower urinary tract symptoms [Three months]

   1 if symptoms improved, 0 if not

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Chronic interstitial cystitis

• Bladder Pain Syndrome

Exclusion Criteria:

• Acute cystitis

• Bladder cancer

• Chronic prostatitis

• Bladder stone

• Stress incontinence

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Basri Cakiroglu	Istanbul		Turkey	34768
2	Hisar Intercontinental Hospital	Istanbul		Turkey	34768

Sponsors and Collaborators

• Hisar Intercontinental Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Basri Cakiroglu, Principal Investigator, Hisar Intercontinental Hospital
• ClinicalTrials.gov Identifier: NCT05744908
• Other Study ID Numbers: 10.01.2023/37
• First Posted: Feb 27, 2023
• Last Update Posted: Feb 27, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Cystitis; Cystitis, Interstitial; Pentosan Sulfuric Polyester

Study Results

No Results Posted as of Feb 27, 2023